Manufacturing Operator

3 months ago

Steinbach, Canada Bausch Health Companies Full time

Join a team We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.

We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.

We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.

**PRINCIPALES RESPONSABILITÉS**:

- Travaillera en étroit collaboration avec les experts de divers secteurs de l'usine et assurera un support pour l’écriture, l’enquête et le suivi des investigations de non conformités amorcer par l’usine, tout en assurant une investigation conforme, complet et un respect des échéances.
- Révisera les preuves fournies par les experts versus les hypothèses émises initialement, validera les hypothèses émises, et déterminera la cause probable de la non-conformité en collaboration avec les experts.
- Documentera l’évaluation des risques et impacts qualité potentiels liés à l’écart et statuera sur la disposition finale du ou des lot(s) affecté(s).
- Rédiger la conclusion finale de l’investigation pour la soumettre pour approbation.
- Déterminer avec les experts le(s) actions correctives et préventives (CAPA) ou demandes de changement (CR) selon la ou les causes probables identifiées afin de prévenir les récurrences.
- Participer selon le cas, aux projets d’amélioration continue et assister aux rencontres quotidiennes de l’usine (DMS et Tier 2).

**EXIGENCES**:

- Diplôme universitaire de premier cycle en sciences
- Minimum 5 ans d’expérience en milieu pharmaceutique
- Minimum 3 ans d’expérience en Assurance de la qualité spécifiquement relier aux investigations de non-conformités et de préférence occupant un rôle d’Investigateur expérimenté.
- Connaissance prouvée des réglementations BPF canadiennes, américains et internationales.
- Excellente connaissance et compréhension des processus de production de produits pharmaceutiques.
- Excellentes communications écrites et parlées en français et en anglais

**PRINCIPAL RESPONSABILITES**:

- Works in close collaboration with experts from various sectors of the plant and provide support for the writing, investigation and follow-up of nonconformities initiated by the factory, ensuring a complete and fully conforming investigation, and completion within established timelines.
- Review the evidence provided by the experts versus the hypothesis determined initially, validate or invalidate each hypothesis, and determine the probable cause of the non-compliance in collaboration with the experts.
- Document the assessment of potential risks and quality impacts related to the deviation and conclude on the final disposition of the affected lot (s).
- Complete the final disposition of the investigation to submit for approval.
- Determine with the experts the corrective and preventive actions (CAPA) or change requests (CR) according to the probable cause (s) identified to effectively prevent recurrences.
- Participate, as appropriate, in continuous improvement projects and attend daily plant meetings (DMS and Tier 2)

**REQUIREMENTS**:

- Undergraduate university degree in science
- Minimum 5 years of experience in the pharmaceutical industry
- Minimum 3 years’ experience in Quality Assurance specifically related to investigations of nonconformities and previously occupying an Investigator role.
- Proven knowledge of Canadian, US and international GMP regulations.
- A strong knowledge and understanding of pharmaceutical production processes
- Excellent written and spoken communications in French and English

**Ce poste peut être disponible aux endroits suivants : location_obj**

Pour en savoir plus, veuillez lire la déclaration de Bausch Health sur la fraude aux offres d'emploi.

**This position may be available in the following location(s): CA - Laval**

Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are comm

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